CN101152157A - Meloxicam orally disintegrating tablets and method for preparing the same - Google Patents
Meloxicam orally disintegrating tablets and method for preparing the same Download PDFInfo
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- CN101152157A CN101152157A CNA2006101167411A CN200610116741A CN101152157A CN 101152157 A CN101152157 A CN 101152157A CN A2006101167411 A CNA2006101167411 A CN A2006101167411A CN 200610116741 A CN200610116741 A CN 200610116741A CN 101152157 A CN101152157 A CN 101152157A
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- meloxicam
- orally disintegrating
- adhesive
- lubricant
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Abstract
The invention discloses a meloxicam orally disintegrating tablet, which is of reasonable formula and good vioavailability, and the preparation method. The content of the principal agent of the meloxicam orally disintegrating tablet, meloxicam, is 5 to 20 percent. The excipient contains disintegrant, diluent or binder, adhesive, sweetener, arom atic agent, lubricant, etc. The preparation method adopts modern preparation technology and the product has stable quality. So the preparation method provides patients with safe and effective meloxicam orally disintegrating tablet.
Description
Technical field
The invention belongs to the medicine preparation field, be specifically related to a kind of meloxicam orally disintegrating tablets that adopts modern tablet technology preparation and preparation method thereof.
Background technology
Meloxicam is a kind of novel former times health non-steroid antiphlogistic by the exploitation of German Boehringer Ingelheim company, 1996 successively in South Africa, Britain's listing, its dosage form has tablet and suppository.The characteristics of meloxicam maximum are that selectivity suppresses II type cyclooxygenase (COX-2), are mainly used in treatment rheumatoid arthritis and osteoarthritis, also can be used for antipyretic-antalgic.Compare advantages such as the intestines and stomach that it has, and antiinflammatory action is strong, anti-inflammatory pain long action time, analgesic effective while significantly reduce non-steroid antiinflammatory drug and kidney side effect with traditional nonsteroidal anti-inflammatory drug of present use.
At present,, all have defective in various degree although meloxicam has various peroral dosage forms, as take inconvenience, medicine stripping slowly, preparation technology comparatively falls behind etc.Since oral cavity disintegration tablet compare with other preparations take more convenient, improved patient's drug compliance, can produce excellent curative, so it is reasonable to produce a kind of prescription, eutherapeutic medicine oral disintegrated preparation and technology of preparing thereof have become one of high-tech technology of contemporary field of medicaments.
Summary of the invention
It is reasonable that the technical problem to be solved in the present invention provides a kind of prescription, the meloxicam orally disintegrating tablets that bioavailability is good.
Another object of the present invention provides a kind of preparation method of meloxicam orally disintegrating tablets agent, and it adopts modern technology of preparing, but commercial scale, high efficiency production, and it is stable that product quality keeps.
Meloxicam orally disintegrating tablets of the present invention comprises principal agent and adjuvant, and the weight percent content of its principal agent meloxicam is: 5%～10%.Described adjuvant is by disintegrating agent, dilution/adhesive, binding agent, compositions such as sweeting agent, aromatic, lubricant, and its weight percent content is:
Disintegrating agent 5%～15%
Dilution/adhesive 50%～90%
Sweeting agent 1%～3%
Aromatic 0.5%～2%
Binding agent 1%～3%
Lubricant 0.5%～3%
Select suitable pharmaceutic adjuvant that the oral cavity disintegration tablet of preparation is had a significant impact, preferred adjuvant can make that disintegrate is rapid, mouthfeel good, to the oral mucosa nonirritant etc.So the present invention has carried out preferably adjuvant.
In above-mentioned adjuvant, dilution/adhesive is that mannitol, disintegrating agent are that crospolyvinylpyrrolidone, binding agent are polyvinylpyrrolidone, and sweeting agent is that aspartame, aromatic are that fragrant citrus essence, lubricant are magnesium stearate.
The method for preparing meloxicam orally disintegrating tablets of the present invention is made up of following steps successively: mixing, granulation, drying, granulate, total mixing, tabletting, packing etc.Its concrete steps are as follows:
1) mix: with meloxicam raw material and mannitol, the premixing in three-phase granulator of partial cross-linked polyvinylpyrrolidone;
2) granulate: in last step mixed powder, add polyvinylpyrrolidone 50% alcohol-water solution and granulate;
3) drying: wet granular is poured out stand, back dish, places 60 ℃ of dryings in the baking oven;
4) granulate: 26 order granulate sieve;
5) the total mixing: pour the granule of aspartame, fragrant citrus essence and residue crospolyvinylpyrrolidone and previous step acquisition in three-dimensional mixer mix homogeneously, add magnesium stearate again and mix;
6) tabletting: mixed material is poured in the hopper of tablet machine, the heavy and pressure of adjustment sheet, carrying out tabletting and keeping slice, thin piece hardness is 20～40N;
7) packing: two aluminum cold forming blister packages.
The meloxicam orally disintegrating tablets that the present invention makes has the following advantages:
1) disintegration rate is fast, and bioavailability is good.2) taking convenience can be swallowed by common dose, can be placed in the water again to take after the disintegrate, can also not need to take medicine with water swallow, is particularly useful for the patient of old man, children's's dysphagia and the inconvenient person that fetches water and takes medicine convenience is provided.Other owing to adopted certain method of improving the preparation mouthfeel, has improved the drug compliance of child patient when this tablet of preparation, preferably resolve the problem that it is difficult that infant is taken medicine.3) intestinal is residual few, and side effect is low.
The specific embodiment
Embodiment 1
Meloxicam 100g
Mannitol 1200g
Crospolyvinylpyrrolidone 150g
Aspartame 20g
Fragrant citrus essence 12g
Polyvinylpyrrolidone 20g
Magnesium stearate 12g
With meloxicam raw material and mannitol, the premixing in three-phase granulator of partial cross-linked polyvinylpyrrolidone; Adding polyvinylpyrrolidone 50% alcohol-water solution in last step mixed powder granulates; Wet granular is poured out stand, back dish, places the interior 60 ℃ of dryings of baking oven 5 hours; 26 order granulate sieve; Aspartame, fragrant citrus essence and residue crospolyvinylpyrrolidone poured into the granule that previous step obtains mix 30 minutes in the three-dimensional mixer, add magnesium stearate mixing 1～2 minute again; Mixed material is poured in the hopper of tablet machine, the heavy and pressure of adjustment sheet, carrying out tabletting and keeping slice, thin piece hardness is 20～40N; Two aluminum cold forming blister packages.
Embodiment 2
Meloxicam 100g
Mannitol 800g
Crospolyvinylpyrrolidone 95g
Aspartame 15g
Fragrant citrus essence 10g
Polyvinylpyrrolidone 15g
Magnesium stearate 10g
With meloxicam raw material and mannitol, the premixing in three-phase granulator of partial cross-linked polyvinylpyrrolidone; Adding polyvinylpyrrolidone 50% alcohol-water solution in last step mixed powder granulates; Wet granular is poured out stand, back dish, places the interior 60 ℃ of dryings of baking oven 4 hours.26 order granulate sieve; Aspartame, fragrant citrus essence and residue crospolyvinylpyrrolidone poured into the granule that previous step obtains mix 30 minutes in the three-dimensional mixer, add magnesium stearate mixing 1～2 minute again; Mixed material is poured in the hopper of tablet machine, the heavy and pressure of adjustment sheet, carrying out tabletting and keeping slice, thin piece hardness is 20～40N; Two aluminum cold forming blister packages.
Embodiment 3
Meloxicam 100g
Mannitol 1500g
Crospolyvinylpyrrolidone 175g
Aspartame 25g
Fragrant citrus essence 17g
Polyvinylpyrrolidone 25g
Magnesium stearate 17g
With meloxicam raw material and mannitol, the premixing in three-phase granulator of partial cross-linked polyvinylpyrrolidone; Adding polyvinylpyrrolidone 50% alcohol-water solution in last step mixed powder granulates; Wet granular is poured out stand, back dish, places the interior 60 ℃ of dryings of baking oven 7 hours; 26 order granulate sieve; Aspartame, fragrant citrus essence and residue crospolyvinylpyrrolidone poured into the granule that previous step obtains mix 30 minutes in the three-dimensional mixer, add magnesium stearate mixing 1～2 minute again; Mixed material is poured in the hopper of tablet machine, the heavy and pressure of adjustment sheet, carrying out tabletting and keeping slice, thin piece hardness is 20～40N; Two aluminum cold forming blister packages.
Claims (4)
1. a meloxicam orally disintegrating tablets comprises principal agent and adjuvant, it is characterized in that the weight percent content of described principal agent meloxicam is: 5%～10%.
2. a meloxicam orally disintegrating tablets as claimed in claim 1 is characterised in that described adjuvant by disintegrating agent, dilution/adhesive, binding agent, compositions such as sweeting agent, aromatic, lubricant, and its weight percent content is:
Disintegrating agent 5%～15%
Dilution/adhesive 50%～90%
Sweeting agent 1%～3%
Aromatic 0.5%～2%
Binding agent 1%～3%
Lubricant 0.5%～3%
3. meloxicam orally disintegrating tablets as claimed in claim 2, be characterised in that dilution/adhesive is that mannitol, disintegrating agent are that crospolyvinylpyrrolidone, binding agent are polyvinylpyrrolidone, sweeting agent is that aspartame, aromatic are that fragrant citrus essence, lubricant are magnesium stearate.
4. the preparation method of a meloxicam orally disintegrating tablets as claimed in claim 1, its preparation process is as follows:
1) with meloxicam raw material and dilution/adhesive, the premixing in three-phase granulator of part disintegrating agent;
2) adding binding agent 50% alcohol-water solution in last step mixed powder granulates;
3) wet granular is poured out stand, back dish, places 60 ℃ of dryings in the baking oven;
4) the 26 order granulate that sieve;
5) pour the granule of sweeting agent, aromatic and residue disintegrating agent and previous step acquisition in three-dimensional mixer mix homogeneously, add mix lubricant again;
6) mixed material is poured in the hopper of tablet machine, the heavy and pressure of adjustment sheet, carrying out tabletting and keeping slice, thin piece hardness is 20～40N.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006101167411A CN101152157A (en) | 2006-09-29 | 2006-09-29 | Meloxicam orally disintegrating tablets and method for preparing the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2006101167411A CN101152157A (en) | 2006-09-29 | 2006-09-29 | Meloxicam orally disintegrating tablets and method for preparing the same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101152157A true CN101152157A (en) | 2008-04-02 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2006101167411A Pending CN101152157A (en) | 2006-09-29 | 2006-09-29 | Meloxicam orally disintegrating tablets and method for preparing the same |
Country Status (1)
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| CN (1) | CN101152157A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103054872A (en) * | 2013-01-24 | 2013-04-24 | 宁夏康亚药业有限公司 | Meloxicam pharmaceutical composition and preparation method thereof |
| CN103099791A (en) * | 2011-11-15 | 2013-05-15 | 海南澳美华制药有限公司 | Oral composition of meloxicam capable of increasing dissolution rate |
| CN103877048A (en) * | 2014-03-26 | 2014-06-25 | 邵娜 | Orally-disintegrating progesterone tablet and preparation method thereof |
| CN104042578A (en) * | 2014-06-13 | 2014-09-17 | 青岛市市立医院 | Domperidone orally disintegrating tablet and preparation method thereof |
-
2006
- 2006-09-29 CN CNA2006101167411A patent/CN101152157A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103099791A (en) * | 2011-11-15 | 2013-05-15 | 海南澳美华制药有限公司 | Oral composition of meloxicam capable of increasing dissolution rate |
| CN103054872A (en) * | 2013-01-24 | 2013-04-24 | 宁夏康亚药业有限公司 | Meloxicam pharmaceutical composition and preparation method thereof |
| CN103054872B (en) * | 2013-01-24 | 2014-06-04 | 宁夏康亚药业有限公司 | Meloxicam pharmaceutical composition and preparation method thereof |
| CN103877048A (en) * | 2014-03-26 | 2014-06-25 | 邵娜 | Orally-disintegrating progesterone tablet and preparation method thereof |
| CN104042578A (en) * | 2014-06-13 | 2014-09-17 | 青岛市市立医院 | Domperidone orally disintegrating tablet and preparation method thereof |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20080402 |